Iovance Biotherapeutics (IOVA) announced updated clinical results from a cohort of the phase II IOV-COM-202 study evaluating the combination of its recently approved cell therapy Amtagvi and Merck’s blockbuster oncology drug Keytruda in frontline advanced melanoma.Based on a recent data cut that included 23 patients, treatment with the Amtagvi/Keytruda combo achieved a confirmed objective response rate (ORR) of 65.2%, including a complete responses (CR) rate of 30.4%. Management noted that ‘nearly all’ resp ...

SAN CARLOS, Calif., May 17, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer, today announced that on May 16, 2024 (the “Date of Grant”), the Company approved the grant of inducement stock options covering an aggregate of 153,930 shares of Iovance’s common stock to thirty new, non-executive emplo ...

Investors are misunderstanding when the biopharma company's flagship drug will begin generating meaningful reportable revenue.Iovance Biotherapeutics (IOVA -19.07%) shares are down to the tune of 18% today following Thursday evening's release of its first-quarter numbers. The sell-off clearly suggests investors didn't like everything they heard. The knee-jerk response to the news, however, looks past a critical detail regarding the report.An irrelevant quarterly reportIovance Biotherapeutics did $715,000 wo ...

Iovance Biotherapeutics, Inc. (IOVA) incurred a loss of 42 cents per share in first-quarter 2024, narrower than the Zacks Consensus Estimate of a loss of 45 cents. In the year-ago quarter, the company reported a loss of 50 cents.During the quarter, the company generated total revenues of $0.7 million — entirely from product sales of its recently-acquired interleukin-2 (IL-2) product Proleukin (aldesleukin). The reported sales missed the Zacks Consensus Estimate of $2.9 million. In the year-ago quarter, Iova ...

财务数据和关键指标变化 - 公司在2024年第一季度实现收入715,000美元,主要来自于授权外市场的Proleukin销售 [47] - 研发费用为7,980万美元,较2023年同期下降290万美元,主要是由于Amtagvi商业化生产的过渡 [48] - 销售、一般及管理费用为3,140万美元,较2023年同期增加330万美元,主要是由于员工人数增加和相关成本增加 [49] - 公司预计2024年全年现金消耗将在3.2亿美元至3.4亿美元之间,不包括一次性费用 [50] 各条业务线数据和关键指标变化 - 公司正在推进Amtagvi在晚期黑色素瘤一线治疗适应症的III期注册性临床试验TILVANCE-301 [54] - 公司重启了肺癌适应症的II期注册性临床试验IOV-LUN-202,并计划在2025年完成注册性队列的入组 [57][59] - 公司计划启动一项II期临床试验,评估Amtagvi在复发/耐药内膜癌患者中的疗效 [60][61] 各个市场数据和关键指标变化 - 公司正在推进Amtagvi在欧洲、英国和加拿大的监管提交,有望在2025年底前在这些市场实现收入 [20] - 公司目标在2024年底前将Amtagvi授权治疗中心(ATC)数量扩大至至少70家,这将创下细胞治疗产品上市的最高ATC数量 [16][26] 公司战略和发展方向及行业竞争 - 公司正在开发多项新一代基因改造TIL细胞治疗产品,包括IOV-4001、IOV-3001和IOV-5001,以巩固在TIL细胞治疗领域的领导地位 [62][63][65] - 公司正在扩大ICTC制造中心的产能,未来有望满足超过10,000名患者的年度需求 [39][40][41] 管理层对经营环境和未来前景的评论 - 公司对Amtagvi在美国的商业化发展保持乐观,预计将在2024年下半年和2025年及以后带来大量收入 [50] - 公司认为制造能力和产能的提升为细胞治疗产品上市设立了新的标准 [32][33][34][35][36] 问答环节重要的提问和回答 问题1 **Michael Yee 提问** 提问了从患者入组到获得报销再到制造和输注的整个过程,询问了第二季度和第三季度可能输注的患者数量 [70][71] **Dr. Fred Vogt 回答** 回答了从患者入组到输注的整个流程,并表示第二季度和第三季度会有大部分患者完成输注 [73][74][75] 问题2 **Andrea Tan 提问** 询问了已入组100多名患者中具体有多少完成了肿瘤切除,以及有多少完成了输注 [77] **Dr. Fred Vogt 回答** 表示无法提供具体数字,因为那样就意味着已经有了收入确认,但表示已有大部分患者完成了切除,正在推进制造和输注的流程 [78][79] 问题3 **Peter Lawson 提问** 询问了100多名已入组患者中有多少有保险报销,以及有多少ATC已经完成了患者切除 [82][83] **Dr. Fred Vogt 和 Jim Ziegler 回答** 表示几乎所有入组患者都有保险或自付,但具体数字不便透露。对于完成切除的ATC数量也表示无法透露具体数字,但正在快速增加 [83][84][85][86]

Table of Contents +- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number 001-36860 IOVANCE BIOTHERAPEUTICS, INC. (Exact name of issuer as specified in its charter) Delaware 75-3254381 (State or ot ...

Exhibit 99.1 Iovance Biotherapeutics Reports First Quarter 2024 Financial Results and Corporate Updates Strong Momentum for Amtagvi™ (Lifileucel) U.S. Launch Following U.S. Food and Drug Administration (FDA) Approval 100+ Amtagvi Patients Enrolled Across More Than 40 Current Authorized Treatment Centers (ATCs), with ~50 Total ATCs On Track by End of May and 70+ Total ATCs by Year-End 2024 Amtagvi Regulatory Submissions on Track in the European Union (EU), United Kingdom (UK), and Canada in 2024 SAN CARLOS, ...

文章核心观点 - Iovance Biotherapeutics 将于5月9日发布2024年第一季度财报 [1] - 公司上一季度的业绩低于预期2.27% [1] - 本季度收入和亏损预计较去年同期有所改善 [2] 公司情况总结 - Iovance 拥有两款上市产品:Amtagvi和Proleukin [3] - Amtagvi在2月获得FDA加速批准用于治疗晚期黑色素瘤,预计本季度销售会较为温和 [4] - Amtagvi还在进行II期临床试验,用于治疗宫颈癌,预计将支持针对宫颈癌的BLA申报 [5] - 公司还在评估LN-145治疗头颈部鳞状细胞癌和非小细胞肺癌的II期临床试验 [6] - 临床试验IOV-LUN-202的临床hold已被FDA解除,该试验评估LN-145治疗非小细胞肺癌 [7] - 公司计划在2024年上半年启动一款新的子宫内膜癌细胞治疗项目 [8] 财务和股价表现 - 公司股价今年以来上涨67.7%,而同期行业下跌5.7% [9] - 公司过去4个季度的业绩表现参差不齐,平均超预期20.05% [10] - 本季度公司预计无法超预期,因为其Earnings ESP为0% [13][14] 同行业公司表现 - ANI Pharmaceuticals有9.74%的Earnings ESP和2级买入评级,有望超预期 [15][16] - argenx有10%的Earnings ESP和3级持有评级,过去4季度平均超预期14.18% [16][17] - AnaptysBio有8.36%的Earnings ESP和3级持有评级,过去4季度平均负超预期4.05% [17][18]

Iovance Biotherapeutics (NASDAQ: IOVA) stock price has rebounded sharply in the past few days as traders wait for the upcoming financial results. It rose by almost 6% on Friday and by over 3% on Monday. It has jumped to $14, almost 28% above its lowest point in April.Are you looking for signals & alerts from pro-traders? Sign-up to Invezz Signals™ for FREE. Takes 2 mins.Iovance earnings aheadCopy link to sectionIovance Biotherapeutics has been one of the best-performing companies on Wall Street as it soared ...

SAN CARLOS, Calif., May 01, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, will report its first quarter 2024 financial results on Thursday, May 9, 2024. Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. ET. To listen to the live or archived aud ...